Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

NCT05326360 | Completed Phase 4

• 1 other identifier: 2012-001-108
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the effectiveness of additional ramosetron injection for controlling late postoperative nausea and vomiting (PONV) after breast surgery in high risk PONV patients. The investigators compared PONV amomng 3 groups- group C: no additional ramosteron, group B: two additional ramosteron doses at 12 hour interval, group M: two additional ramosetron doses mix to the intraveonus patient controlled analgesia.

Conditions

Postoperative Nausea and Vomiting; Breast Cancer Female

Keywords

mastectomy; postoperative nausea and vomiting; ramosetron

Outcome Measures

Primary Outcomes (1)

• number of PONV

  number of nausea, vomiting, retching

  24hour postoperatively

Secondary Outcomes (2)

• number of PONV

  1hour, 6hour, 48 hour postoperatively

• Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score

  1hour, 6hour, 24hour, 48 hour postoperatively

Study Arms (3)

group C

NO INTERVENTION

receive ramosetron i.v. 0.3mg at the end of surgery without additional ramosetron

group B

EXPERIMENTAL

receive ramosetron i.v. 0.3mg at the end of surgery with two additional doses of ramosetron at 12- and 24- hour postoperative time points

Drug: Ramosetron Hydrochloride

group M

EXPERIMENTAL

receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen

Drug: Ramosetron Hydrochloride

Interventions

Ramosetron Hydrochloride DRUG

we injected two additional remosetron doses in different way in experimental groups. In group B, patients received additional ramosetron at 12 hour interval, in group M, patients received additional ramosetron in mixed with the patient controlled analgesia regimen.

group B; group M

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years
• American Society of Anesthesiologists (ASA) physical status I or II
• requesting IV PCA (patient control of analgesia) for pain control
• the high-risk group of PONV with a score of 3 or more as measured by the Apfel's score.

You may not qualify if:

• emergency operation
• re-operation
• drug abuse, allergy
• major organ disease (gastrointestinal, cardiovascular, respiratory, cerebral, renal or hepatic disease)
• smoker
• pregnancy
• lactation
• previously use of antiemetics or systemic steroids within 48 before surgery

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hopsital

Busan, 49241, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 13, 2022
• Study Start: December 17, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

KR (1)